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NCT02319837 · OUTCOME

Time to Distant Metastasis

Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK) · Source last updated 2026-07-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
From randomization until the earliest objective evidence of distant soft tissue metastases or metastatic bone disease (up to Month 98)

What was measured

The time to distant metastasis was defined as the time in months from randomization to the earliest objective evidence of distant soft tissue metastases or metastatic bone disease by blinded independent central review (BICR).

Analysis population: The ITT population was used for analysis, and it included all participants randomly assigned to study treatment.

Groups in this outcome

Enzalutamide + Leuprolide

Participants were randomized to receive enzalutamide capsules 160 milligrams (mg)/day, plus leuprolide 22.5 mg intramuscular or subcutaneous injection once every 12 weeks from Day 1. Study treatment continued uninterrupted in the absence of disease progression until the central laboratory prostate-specific antigen (PSA) evaluation at Week 36. At week 37 study treatment was suspended for participants whose PSA values were undetectable at Week 36 and was reinitiated if subsequent PSA values increased to the threshold specified for reinitiation of study treatment. Participants with detectable PSA values at Week 36 continued treatment without suspension until permanent treatment discontinuation criteria were met.

Placebo + Leuprolide

Participants were randomized to receive placebo capsules once daily, plus leuprolide 22.5 mg intramuscular or subcutaneous injection once every 12 weeks from Day 1. Study treatment continued uninterrupted in the absence of disease progression until the central laboratory PSA evaluation at Week 36. At week 37 study treatment was suspended for participants whose PSA values were undetectable at Week 36 and was reinitiated if subsequent PSA values increased to the threshold specified for reinitiation of study treatment. Participants with detectable PSA values at Week 36 continued treatment without suspension until permanent treatment discontinuation criteria were met.

Enzalutamide Monotherapy

Participants were randomized to receive enzalutamide capsules 160 mg/day from Day 1. Study treatment continued uninterrupted in the absence of disease progression until the central laboratory PSA evaluation at Week 36. At week 37 study treatment was suspended for participants whose PSA values were undetectable at Week 36 and was reinitiated if subsequent PSA values increased to the threshold specified for reinitiation of study treatment. Participants with detectable PSA values at Week 36 continued treatment without suspension until permanent treatment discontinuation criteria were met.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Enzalutamide + Leuprolide355
Placebo + Leuprolide358
Enzalutamide Monotherapy355

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Enzalutamide + LeuprolideNANot reportedNANANA indicates not estimable due to small number of events.
Placebo + LeuprolideNANot reported85.1NANA indicates not estimable due to small number of events.
Enzalutamide MonotherapyNANot reportedNANANA indicates not estimable due to small number of events.

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.284
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.690
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.
    non Inferiority Type
    OTHER
    p Value
    0.0002
    param Type
    Hazard Ratio (HR)
    param Value
    0.443
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.409
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.920
    group Ids
    1. OG001
    2. OG002
    non Inferiority Comment
    Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.
    non Inferiority Type
    OTHER
    p Value
    0.0171
    param Type
    Hazard Ratio (HR)
    param Value
    0.614
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.284
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.690
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.
    non Inferiority Type
    OTHER
    p Value
    0.0002
    param Type
    Hazard Ratio (HR)
    param Value
    0.443
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.409
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.920
    group Ids
    1. OG001
    2. OG002
    non Inferiority Comment
    Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.
    non Inferiority Type
    OTHER
    p Value
    0.0171
    param Type
    Hazard Ratio (HR)
    param Value
    0.614
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        NA indicates not estimable due to small number of events.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        NA indicates not estimable due to small number of events.
        group Id
        OG001
        lower Limit
        85.1
        upper Limit
        NA
        value
        NA
      3. comment
        NA indicates not estimable due to small number of events.
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      355
    2. group Id
      OG001
      value
      358
    3. group Id
      OG002
      value
      355
    units
    Participants
description
The time to distant metastasis was defined as the time in months from randomization to the earliest objective evidence of distant soft tissue metastases or metastatic bone disease by blinded independent central review (BICR).
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants were randomized to receive enzalutamide capsules 160 milligrams (mg)/day, plus leuprolide 22.5 mg intramuscular or subcutaneous injection once every 12 weeks from Day 1. Study treatment continued uninterrupted in the absence of disease progression until the central laboratory prostate-specific antigen (PSA) evaluation at Week 36. At week 37 study treatment was suspended for participants whose PSA values were undetectable at Week 36 and was reinitiated if subsequent PSA values increased to the threshold specified for reinitiation of study treatment. Participants with detectable PSA values at Week 36 continued treatment without suspension until permanent treatment discontinuation criteria were met.
    id
    OG000
    title
    Enzalutamide + Leuprolide
  2. description
    Participants were randomized to receive placebo capsules once daily, plus leuprolide 22.5 mg intramuscular or subcutaneous injection once every 12 weeks from Day 1. Study treatment continued uninterrupted in the absence of disease progression until the central laboratory PSA evaluation at Week 36. At week 37 study treatment was suspended for participants whose PSA values were undetectable at Week 36 and was reinitiated if subsequent PSA values increased to the threshold specified for reinitiation of study treatment. Participants with detectable PSA values at Week 36 continued treatment without suspension until permanent treatment discontinuation criteria were met.
    id
    OG001
    title
    Placebo + Leuprolide
  3. description
    Participants were randomized to receive enzalutamide capsules 160 mg/day from Day 1. Study treatment continued uninterrupted in the absence of disease progression until the central laboratory PSA evaluation at Week 36. At week 37 study treatment was suspended for participants whose PSA values were undetectable at Week 36 and was reinitiated if subsequent PSA values increased to the threshold specified for reinitiation of study treatment. Participants with detectable PSA values at Week 36 continued treatment without suspension until permanent treatment discontinuation criteria were met.
    id
    OG002
    title
    Enzalutamide Monotherapy
param Type
MEDIAN
population Description
The ITT population was used for analysis, and it included all participants randomly assigned to study treatment.
reporting Status
POSTED
time Frame
From randomization until the earliest objective evidence of distant soft tissue metastases or metastatic bone disease (up to Month 98)
title
Time to Distant Metastasis
type
SECONDARY
unit Of Measure
Months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice